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microFASTTM GC
For Lexsol Detection
For Lexsol Detection
Protecting Critical Batch Processes and
The Measurement Problem
Many delicate products such as most classes
of pharmaceuticals (especially meds for
injection), food and beverages must be
produced in very clean or sterile environments.
These products are often produced in batches
and can be made in shared vessels and
transport lines. Cleaning the processing
hardware is critical and the condition of the
process must be known before beginning,
during the process cycle if possible and at the
conclusion of production.
Processor Situation
One process where condition monitoring is
absolutely critical is lyophilization (freeze
drying) of blood products. These products are
thermally very sensitive and water based. The
water must be removed for proper
reconstitution as a dose. Freeze drying is
accomplished at temperatures down to -40oC
and at very low pressures (vacuum). Before
beginning, the process is sterilized with high
pressure steam.
The Measurement Problem
Many delicate products such as most classes
of pharmaceuticals (especially meds for
injection), food and beverages must be
produced in very clean or sterile environments.
These products are often produced in batches
and can be made in shared vessels and
transport lines. Cleaning the processing
hardware is critical and the condition of the
process must be known before beginning,
during the process cycle if possible and at the
conclusion of production.
Processor Situation
One process where condition monitoring is
absolutely critical is lyophilization (freeze
drying) of blood products. These products are
thermally very sensitive and water based. The
water must be removed for proper
reconstitution as a dose. Freeze drying is
accomplished at temperatures down to -40oC
and at very low pressures (vacuum). Before
beginning, the process is sterilized with high
pressure steam.
Processor Requirements
The atmospheric composition before and after
processing validates the preprocess
cleanliness “condition” (successful sterilization
and “normal condition”) and post processing
“product quality” (absence of coolant leaks or
any other “contaminants”). Definitive
composition concentrations below the action
limit are necessary. In addition to meeting the
measurement requirements, the system must
be at least semi-automated and easy for
operations staff to use.
The Solution
The microFASTTM GC coupled with an
automated sampling system is capable of
measuring the contaminants at the ppb level.
Common coolants are Lexsol and Siltherm.
Detection limits for either are below 5 ppb --
far below the levels that would be produced if a
leak occurred. Both coolants are within the C2-
C24 chain length capability of the GC.
EZChrom for instrument and sample system
control has the tools necessary for calibration,
alarming, data and report generation, including
the automation functions.
The atmospheric composition before and after
processing validates the preprocess
cleanliness “condition” (successful sterilization
and “normal condition”) and post processing
“product quality” (absence of coolant leaks or
any other “contaminants”). Definitive
composition concentrations below the action
limit are necessary. In addition to meeting the
measurement requirements, the system must
be at least semi-automated and easy for
operations staff to use.
The Solution
The microFASTTM GC coupled with an
automated sampling system is capable of
measuring the contaminants at the ppb level.
Common coolants are Lexsol and Siltherm.
Detection limits for either are below 5 ppb --
far below the levels that would be produced if a
leak occurred. Both coolants are within the C2-
C24 chain length capability of the GC.
EZChrom for instrument and sample system
control has the tools necessary for calibration,
alarming, data and report generation, including
the automation functions.
